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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM FINISH GUIDE SZ 6 ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

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DEPUY IRELAND - 9616671 ATTUNE FEM FINISH GUIDE SZ 6 ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2544-00-026
Device Problem Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint #
==
> (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the instrument to be worn. The part that guides the saw is worn. An exact cutting-preparation is no longer possible. No adverse patient consequences, no surgical delay.
 
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Brand NameATTUNE FEM FINISH GUIDE SZ 6
Type of DeviceATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12851224
MDR Text Key281088125
Report Number1818910-2021-25904
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2544-00-026
Device Catalogue Number254400026
Device Lot NumberABB97158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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